Feasibility of a Campaign Intervention Compared to a Standard Behavioral Weight Loss Intervention in Overweight and Obese Adults: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Feasibility of a Campaign Intervention Compared to a Standard Behavioral Weight Loss Intervention in Overweight and Obese Adults (NCT01803737), a randomized na study. The primary outcome is Change in Body Weight.

2. Clinical Question

The trial asked whether a campaign intervention for weight management could be evaluated alongside a standard behavioral weight loss intervention in overweight and obese adults. Its stated purpose was to examine feasibility. The primary outcome was change in body weight from week 0 to week 12, comparing participants assigned to the Campaign Intervention (CI) with participants assigned to the Standard Behavioral Weight Loss Intervention (SBWL).

The record describes a feasibility study, not a definitive test of effectiveness. The central statistical comparison is the difference in mean weight change between the randomized groups. Other registered outcomes covered physical activity, dietary intake, self-monitoring, self-efficacy, and motivation. Those outcomes can add context about measured behavior and participant processes, but they do not replace the primary weight-change comparison or establish feasibility on their own.

3. Trial Design

The study was randomized, used a parallel-group design, and had no masking. The registry record lists an enrollment of 26 participants. The posted primary-outcome results include 13 participants in the SBWL group and 13 in the CI group. The study was marked completed. Its recorded start was 2013-01, and its primary completion was 2013-07.

Both groups received behavioral interventions focused on eating behavior and physical activity. The SBWL description specifies regular group weight loss meetings. The CI description specifies that participants would not attend regular meetings, but would attend meetings at weeks 0 and 12; the description of additional contact during weeks 1-11 is incomplete in the registry record. The intended intervention period was 12 weeks, with body weight measured at week 0 and week 12.

Random allocation can help balance participant characteristics across groups on average, but it does not ensure balance in a trial with few participants. With only 13 participants per group in the posted primary results, group means and their comparison can be sensitive to individual observations. The design was also unmasked, so participants and study personnel were not blinded according to the registry entry. The record does not describe how outcome assessors were handled.

The sponsor was the University of Pittsburgh. The registry lists the condition as weight loss and the phase as not applicable. The original rationale for the enrollment target, detailed eligibility criteria, recruitment setting, allocation procedure, and any stratification factors are not reported in the registry record. The record also does not establish whether the posted results include every randomized participant or how participants with unavailable follow-up measurements were handled.

4. Participant Flow and Accounting

The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.

Overall Study

Reasons for not completing this period:

5. Baseline Characteristics

The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.

Population: Statistical analyses were performed using the Statistical Package for the Social Sciences (IBM-SPSS, version 21.0). Statistical significance was accepted at the p\<0.05 level of confidence. Analyses were conducted using individuals who completed assessments at week 0 and 12, with intent-to-treat (ITT) analysis carrying the baseline data forward.

6. Primary Endpoint

The registry lists the primary outcome as Change in Body Weight, measured over Week 0 and 12.

The primary endpoint was change in body weight, measured in kilograms between week 0 and week 12. The registry description says weight was measured on a digital scale. The reported group summaries are means with standard deviations, so the results describe the average change in each group and the variation among participants within each group.

Change in weight is used as a direct measure of the outcome targeted by the weight-management interventions. Measuring at the start and end of the 12-week period allows the comparison to focus on change during the intervention, rather than only on the weight recorded at one time. The posted mean changes were -5.6 kg for SBWL and -3.1 kg for CI. The reported mean difference for CI relative to SBWL was 2.5 kg, with a confidence interval from 0.071 to 4.929 kg and an unadjusted p-value of 0.044.

These figures describe the observed group summaries and their comparison. They do not, by themselves, explain why participants changed weight, establish whether the groups were similar at the outset, or show how weight change persisted after week 12. Further follow-up results are not reported in the registry record.

7. Results Posted in the Registry

• Campaign Intervention (CI): mean -3.10 versus -5.60 on control; difference 2.50 (95% CI 0.07 to 4.93), standardized effect d = 0.79; z-test p = 0.044.

8. Secondary Efficacy Endpoints

The registry also posts results for secondary outcomes. For each outcome below, the endpoint type, the test applied to the posted summary statistics, the result and its interpretation are given in turn. Secondary endpoints are usually not adjusted for multiple testing, so they support rather than confirm the primary finding.

Change in Physical Activity

• Endpoint type: Continuous: a mean value per participant, compared as a difference in means.
• Test: Unadjusted two-sample z-test for the difference in means, using the posted standard deviations.
• Result:
  • Campaign Intervention (CI): mean 776.30 versus 983.30 on control; difference -207.00 (95% CI -926.05 to 512.05), standardized effect d = -0.22; z-test p = 0.573.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Campaign Intervention (CI) and the control. The interval gives the range of effects that remain compatible with the data.

Change in Dietary Intake: Kcals/Day

• Endpoint type: Continuous: a mean value per participant, compared as a difference in means.
• Test: Unadjusted two-sample z-test for the difference in means, using the posted standard deviations.
• Result:
  • Campaign Intervention (CI): mean 242.50 versus 474.80 on control; difference -232.30 (95% CI -706.88 to 242.28), standardized effect d = -0.38; z-test p = 0.337.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Campaign Intervention (CI) and the control. The interval gives the range of effects that remain compatible with the data.

Change in Dietary Intake: % Fat

• Endpoint type: Continuous: a mean value per participant, compared as a difference in means.
• Test: Unadjusted two-sample z-test for the difference in means, using the posted standard deviations.
• Result:
  • Campaign Intervention (CI): mean -0.00 versus -3.26 on control; difference 3.26 (95% CI -0.56 to 7.08), standardized effect d = 0.66; z-test p = 0.094.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Campaign Intervention (CI) and the control. The interval gives the range of effects that remain compatible with the data.

The registered secondary outcomes span physical activity, dietary intake, self-monitoring, weight-loss self-efficacy, and motivation. Numerical comparisons are reported for physical activity, dietary energy intake, and percentage of fat intake. For those measures, the estimates do not all point in the same direction relative to the primary weight-change comparison, and their confidence intervals include zero. Their unadjusted p-values likewise do not provide a clear, consistent pattern of differences across the available measures.

The record does not report numerical results for dietary protein, dietary carbohydrate, completion of self-monitoring, weight-loss self-efficacy, or autonomous and controlled motivation. These outcomes are listed, but their missing numerical results mean they cannot be used to establish whether the two groups differed in those areas. The registry record lists eight secondary outcomes, but only some have posted arm-level numerical summaries and comparisons.

Secondary measures can help describe behavioral changes that may accompany the primary outcome, but they do not independently explain the weight results. In this trial, the available secondary findings are imprecise and do not form a consistent confirmatory pattern. They should not be treated as proof that one intervention changed activity or diet more than the other.

There is also a multiplicity concern: when several outcomes are evaluated, unadjusted results are more susceptible to chance findings. The registry record does not report a correction for multiple comparisons or a hierarchy that would distinguish confirmatory from exploratory outcomes. Accordingly, the secondary results carry less inferential weight than a prespecified primary comparison, and even the primary result needs to be viewed in the context of the small feasibility study and its uncertainty.

Secondary outcomes registered for this trial, for reference (only those above were recalculated):

• Change in Physical Activity
• Change in Dietary Intake: Kcals/Day
• Change in Dietary Intake: % Fat
• Change in Dietary Intake: % Protein
• Change in Dietary Intake: % Carbohydrate
• Completion of Self-monitoring of Dietary Intake and Physical Activity
• Change in Weight Loss Self-efficacy
• Autonomous and Controlled Motivation

9. Statistical Interpretation

10. Statistical Methods Explained

The primary outcome is continuous: each participant has a measured change in body weight, and the registry reports the mean and standard deviation for each group. The mean describes the center of the observed changes. The standard deviation describes how spread out those individual changes are around the mean. It is not the same as the standard error, which describes uncertainty in an estimated mean, or the confidence interval, which describes a range of estimates compatible with the data under a statistical procedure.

What does the mean difference represent?

The reported mean difference compares the CI group with the SBWL group. For the primary outcome, the estimate is 2.5 kg. The sign and direction depend on which group is subtracted from which; the posted comparison expresses CI relative to SBWL. Since the group means are both negative, the positive difference indicates that the mean change in CI was less negative than the mean change in SBWL. This contrast concerns group averages and does not imply that every participant in one group had a larger or smaller change than every participant in the other.

The primary comparison is an unadjusted comparison of the posted group summaries. The registry record lists no reported analyses. The comparison statistics are therefore not a substitute for a detailed analysis plan or an adjusted model. The record does not report covariate adjustments, the exact inferential procedure used for a sponsor analysis, or whether the analysis accounted for any features beyond the two-group comparison.

How should the p-value be read?

A p-value measures how incompatible the observed data, or data more extreme, are with a specified null model under the assumptions of the test. It is not the probability that the null hypothesis is true, and it does not indicate the probability that a result will replicate. The primary unadjusted p-value is 0.044. It should be considered alongside the estimate, confidence interval, sample size, study purpose, and the absence of a reported multiplicity plan. A p-value alone cannot show whether a difference is important or robust.

General statistical context: an unadjusted p-value treats the comparison as though it were considered on its own. When several outcomes are examined, the chance of at least one apparently unusual result can rise if no adjustment or prespecified hierarchy is used. The registry record lists multiple secondary outcomes, but does not report a multiplicity procedure. That makes isolated secondary p-values especially difficult to interpret as confirmatory evidence.

Why does variability matter?

The observed standard deviations differ across measures and groups. Greater participant-to-participant variability makes a group mean less precise when sample size is held fixed. This is one reason the secondary comparisons have wide confidence intervals. For example, the physical-activity results show much more variability in the CI group than in the SBWL group, and the comparison interval extends across a broad range of possible mean differences. The registry record does not report a variance model, a transformation, or an alternative approach for handling unusually variable observations.

General statistical context: over-dispersion means that observed variability is larger than a statistical model expects. If a model assumes less variability than is actually present, its uncertainty estimates can be too narrow and its tests can be misleading. The posted summaries do not establish that over-dispersion occurred under a particular model, and the registry record does not describe a model-based analysis. The general point is that variability should be considered when interpreting estimated differences and their precision.

What can the confidence interval add?

A confidence interval combines the estimated difference with its statistical uncertainty. A narrower interval indicates greater precision under the method used; a wider interval indicates that a wider range of values is compatible with the observed data. The primary interval is entirely above zero but spans from a value close to zero to a much larger positive difference. This helps explain why the point estimate should not be treated as exact. For secondary comparisons, the reported intervals cover zero, so the data are compatible with differences in either direction as well as little or no difference under the stated comparison.

The registry record does not state the confidence level or full method used to form these intervals. Their lower and upper limits can be described as posted, but the analysis procedure should not be inferred beyond what is recorded. The comparison values are unadjusted and based on the available arm summaries; no model-adjusted estimates are reported.

The planning figures associated with the outcomes are separate from the observed trial analysis. They use the observed effect as a planning reference and apply stated assumptions about significance level, allocation, and a normal approximation. They are not evidence that the original trial was designed using those assumptions. The record does not report the original sample-size justification or its intended power.

11. Confidence Intervals and Precision

Precision is most directly assessed by the confidence interval around an estimated difference. For the primary comparison, the reported mean difference is 2.5 kg, with limits of 0.071 and 4.929 kg. The interval is entirely positive, but it spans from near zero to a substantially larger difference. Thus, the posted estimate has uncertainty about the magnitude even though the interval does not include zero.

The small groups are important context for this range. Each arm has 13 participants in the posted primary results. A small sample can produce unstable estimates, particularly when individual observations vary. The primary group standard deviations are 2.9 kg and 3.4 kg, and the record provides no individual values with which to assess outliers or the shape of the distributions. The interval and p-value should therefore be read as summaries of limited data rather than as precise descriptions of a population effect.

For the numerical secondary comparisons, each reported confidence interval includes zero. The physical-activity interval runs from -926.1 to 512.1 kcals/wk, the dietary energy interval from -706.9 to 242.3 kcals/day, and the percentage-of-fat interval from -0.559 to 7.079 percentage points. These ranges allow for differences in either direction and, in each case, indicate limited precision. They do not demonstrate equivalence between the interventions; an interval that includes zero may also include differences that could matter, depending on context.

Confidence intervals are not guarantees that the true difference lies within the stated limits. In general, they reflect the performance of a statistical procedure across repeated studies under its assumptions. The registry record does not give the confidence level or complete interval-construction method, so interpretation should remain tied to the posted limits and avoid stronger claims about coverage or model details.

12. Planning a Similar Trial: Sample Size

This is a planning illustration, not a re-evaluation of the original trial. It asks: if a new study wanted to detect a difference like the one observed, or a smaller one, how large would it need to be? It is deliberately not “observed power” of the finished trial, which is not a meaningful quantity.

The planning figures are participants per arm, not total participants and not total events. They apply to continuous outcomes in this record. The stated planning assumptions are a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation. The effect to detect is set as a stated fraction of the observed effect. The original trial's own design assumptions and sample-size justification are not reported in the registry record.

The 80% power column describes the number of participants per arm estimated to give an 80% chance of detecting the specified effect under those planning assumptions, if that effect is the true one and the model assumptions hold. The 90% power column uses a higher target chance of detection and therefore generally calls for more participants. For the primary weight-change comparison, planning for 100% of the observed effect gives 26 participants per arm for 80% power and 34 per arm for 90% power. Planning for 75% of the observed effect gives 45 and 60 participants per arm, respectively; planning for 50% gives 101 and 135.

Smaller effects are harder to distinguish from random variation, so the planning figures increase as the target effect is reduced. These calculations use the observed effect as a reference, which may be an unstable estimate in a small feasibility study. They are planning illustrations, not observed power and not evidence that the trial had adequate power for its primary or secondary outcomes. The original design target is not reported in the registry record.

13. How the Sample Size Is Derived

Power is the probability that a study of a given size rejects the null hypothesis when a specific true effect exists. It depends on four things: the effect to detect, the variability of the outcome, the significance level (here a two-sided α of 0.05, so z_1−α/2 = 1.960) and the desired power (z_1−β = 0.842 for 80% and 1.282 for 90%).

Formula

n is the number of participants in each arm, Δ is the difference in means to detect and σ is the common standard deviation.

Worked calculation for this trial

1. Observed difference Δ = 2.500; pooled standard deviation σ = 3.160.
2. n = 2 × (1.96 + 0.842)² × 3.160² / 2.500² = 25.1, rounded up to 26 participants per arm for 80% power.

The smaller-effect rows in the table above repeat the same calculation with the effect multiplied by 0.75 and 0.5 (for ratios, applied to the logarithm of the ratio).

R code

alpha <- 0.05
z_a   <- qnorm(1 - alpha / 2)          # two-sided
delta <- 2.5                      # observed difference in means
sigma <- 3.15990506186499                     # pooled standard deviation
n_per_arm <- function(power, frac = 1) {
  ceiling(round(2 * (z_a + qnorm(power))^2 * sigma^2 / (delta * frac)^2, 6))
}
for (f in c(1, 0.75, 0.5))
  cat(sprintf("%3.0f%% of observed effect: n per arm = %s (80%% power), %s (90%% power)\n", 100 * f,
              format(n_per_arm(0.80, f), big.mark = ","), format(n_per_arm(0.90, f), big.mark = ",")))

# Check against R's built-in function (t-based, so very slightly larger)
cat("power.t.test:", round(power.t.test(delta = delta, sd = sigma, power = 0.80)$n, 1), "\n")

# Simulation: exact two-sample t-test using simulated means and variances
set.seed(1803737)
n    <- n_per_arm(0.80)
reps <- 20000
m_diff <- rnorm(reps, delta, sigma * sqrt(2 / n))             # difference in sample means
s2     <- sigma^2 * rchisq(reps, 2 * (n - 1)) / (2 * (n - 1))   # pooled sample variance
tstat  <- m_diff / sqrt(s2 * 2 / n)
cat(sprintf("Simulated power at n = %s per arm: %.3f (%d replicates)\n", format(n, big.mark = ","), mean(abs(tstat) > qt(0.975, 2 * (n - 1))), reps))

Output from running the code

100% of observed effect: n per arm = 26 (80% power), 34 (90% power)
 75% of observed effect: n per arm = 45 (80% power), 60 (90% power)
 50% of observed effect: n per arm = 101 (80% power), 135 (90% power)
power.t.test: 26.1 
Simulated power at n = 26 per arm: 0.804 (20000 replicates)

The simulation draws many sets of group means and variances at the planned sample size and counts how often the two-sample t-test rejects the null. It should land close to the target power; at very small required sample sizes it can fall below it, because the normal approximation is rough there.

14. Multiplicity, Missing Data and Analysis Populations

The registry record identifies one primary outcome and eight secondary outcomes. It does not report whether the investigators used a prespecified hierarchy among outcomes, adjusted significance thresholds, or another procedure to address multiplicity. Without that information, the listed unadjusted p-values should not be interpreted as if each were the sole planned test. Examining several outcomes can increase the chance of a result that appears unusual by chance, especially when the outcomes are not adjusted or otherwise prioritized.

The record does not list reported analyses. It does not describe an intention-to-treat population, a per-protocol population, or another analysis population. The primary outcome summaries include 13 participants in each group, but that fact alone does not establish whether those were all randomized participants with complete outcome data or how missing measurements were handled. A missing-data method, imputation procedure, and sensitivity analysis are not reported in the registry record.

Information about the original statistical analysis plan, protocol deviations, interim analyses, covariate adjustment, and the treatment of outliers is also not reported in the registry record. These omissions limit assessment of whether the posted analysis followed a prespecified plan and how robust the estimates are to alternative choices. They do not establish that particular methods were or were not used; they indicate that the record does not describe them.

The registry lists additional secondary outcomes without numerical results. The absence of those results prevents a full assessment of the complete registered outcome set. It also makes it difficult to determine whether the available secondary results represent all measured outcomes or only those posted with quantitative summaries. Conclusions should remain limited to the endpoints and analyses actually reported.

15. Safety Results

The registry reports serious adverse events as affected participants divided by participants at risk.

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 0% reporting threshold.

The adverse-event figures list 13 participants at risk in each group. The record reports zero serious adverse events affecting participants in SBWL and zero in CI. It also reports zero other adverse events affecting participants in either group. These figures describe the adverse-event entries in the registry; they do not by themselves establish that no event of any kind occurred outside the reporting categories or observation period.

The deaths field is not populated with a numerical value for either group. Deaths are therefore not reported in the registry record, rather than reported as zero. The record provides no serious adverse-event terms because no serious events are listed. It does not describe event definitions, collection methods, follow-up duration for safety, or attribution to an intervention. With 13 participants at risk per group, the absence of a reported event should be read as a limited observation from a small study, not as a precise estimate of event risk.

16. What the Result Does, and Does Not, Mean

The posted results describe the average body-weight changes observed during a 12-week comparison of two behavioral interventions. The mean change was -5.6 kg with SBWL and -3.1 kg with CI; the reported difference for CI relative to SBWL was 2.5 kg. The confidence interval and unadjusted p-value provide statistical context for that comparison, but the estimate is not exact and the sample is small. The data show the results for these groups in this study, not a guaranteed outcome for future participants.

The study was framed as a feasibility investigation. The registry record does not report prespecified feasibility thresholds or a full set of numerical feasibility results. The listed measures include self-monitoring completion, but no numerical result for that measure is posted. Consequently, the weight-change comparison should not be used alone to declare whether the campaign approach was feasible or whether all aspects of its delivery were successful.

The posted comparison also does not establish why the groups had different mean changes. It cannot separate the effects of meeting frequency, intervention content, participant engagement, or other factors. The record does not provide a detailed analysis of adherence, baseline group characteristics, individual weight trajectories, or outcomes after week 12. The study also does not provide evidence about longer-term maintenance.

For secondary outcomes, the available estimates are imprecise and their intervals include zero. Other registered secondary outcomes lack numerical results in the record. Those limitations mean the secondary findings do not provide a clear basis for explaining or confirming the primary comparison. The results should be understood as preliminary descriptive evidence from a small randomized feasibility trial, with uncertainty about the size and generalizability of group differences.

Nothing in these data is a recommendation for an individual. The record does not establish which approach is appropriate for any particular person, and the statistical comparison does not replace clinical judgment or additional evidence.

17. Why This Trial Matters Statistically

This trial illustrates why a statistically notable estimate and a feasibility objective should be considered together rather than treated as the same question. The primary comparison has a reported p-value of 0.044, but it comes from 13 participants per group and has a confidence interval that spans a substantial range. Statistical evidence against a zero difference under an unadjusted comparison does not remove uncertainty about the magnitude, repeatability, or practical meaning of the result.

The trial also illustrates how secondary outcomes can offer context while creating interpretive challenges. Behavioral interventions can be evaluated through weight, activity, dietary intake, and participant processes, but several outcomes increase the need for a clear analysis plan. In this registry record, several secondary outcomes have no numerical results, and the available comparisons are unadjusted. That combination makes it especially important not to single out one secondary result as a definitive finding.

Planning calculations based on an observed effect can help readers understand how sample size relates to precision and detection of smaller effects. They do not reveal the original design rationale. Here, the registry record does not report the trial's original sample-size justification, so the planning illustrations must remain separate from any claim about what the investigators intended or whether the study was adequately sized.

Finally, the record highlights the value of complete reporting for feasibility trials. Clear criteria for feasibility, analysis populations, missing-data handling, multiplicity, and outcome results would help readers distinguish descriptive findings from planned confirmatory evidence. Without those details, the defensible interpretation is limited to the posted summaries and the uncertainty around them.

18. Limitations

• The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
• Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.

The total enrollment was 26, with 13 participants in each group in the posted primary results. That small sample limits precision and makes the estimates potentially sensitive to individual observations. The registry record does not provide participant-level data or demographic summaries, so the degree of group comparability and the range of participant characteristics cannot be assessed from the posted results.

The study was unmasked. The registry does not report how outcome assessment was conducted or whether any steps were taken to reduce the influence of awareness of group assignment. Body weight was measured on a digital scale, but the record does not describe assessor procedures or measurement quality checks. Details of the CI intervention are incomplete in the registry record, particularly for the weeks without in-person meetings.

The intervention period and primary measurement schedule cover week 0 and week 12. The record does not report longer follow-up, so the posted results do not show whether changes persisted. Numerical results are also unavailable for several registered secondary outcomes. The record does not report missing-data methods, analysis-population definitions, multiplicity handling, or the original statistical analysis plan.

Although the stated purpose was to examine feasibility, the record does not provide prespecified criteria for deciding whether the intervention was feasible. The safety entries report no adverse events affecting participants, but the small groups and limited reporting details do not support broad conclusions about safety. These trial-specific limitations restrict interpretation to the short-term posted summaries and leave substantial questions about precision, completeness, and applicability unresolved.

19. Related Tutorials

20. Related Statistical Calculators

21. Sources

• ClinicalTrials.gov: Feasibility of a Campaign Intervention Compared to a Standard Behavioral Weight Loss Intervention in Overweight and Obese Adults — NCT01803737.
• Registry record last updated 2014-02-17; status last verified 2014-01.
• Results first posted 2014-02-17.
• Data retrieved from ClinicalTrials.gov on 2026-11-09.
• Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.

22. Record Summary

NCT01803737 is a completed randomized, unmasked, parallel-group feasibility study sponsored by the University of Pittsburgh. It enrolled 26 overweight and obese adults and compared the Campaign Intervention with the Standard Behavioral Weight Loss Intervention. The intended intervention period was 12 weeks.

The primary outcome was change in body weight from week 0 to week 12. The posted means were -5.6 kg for SBWL and -3.1 kg for CI, with a reported CI-relative-to-SBWL mean difference of 2.5 kg, confidence interval 0.071 to 4.929 kg, and unadjusted p-value 0.044. The record includes numerical results for three secondary measures, while numerical results for other registered secondary outcomes are not reported in the registry record.

The primary comparison is based on 13 participants per group. The record does not report the original sample-size rationale, missing-data method, analysis population, or multiplicity plan. These details, along with the small sample and incomplete secondary results, limit conclusions beyond the posted short-term summaries.